Experience

Aispharma
• Türkiye
• Chemical Manufacturing
• 1 - 100 Employee
• Qualified Person

  • Mar 2023 - Present


Dem Pharmaceuticals A.S.

• Quality Control Manager

  • Nov 2020 - Mar 2023

  • Leading the start-up of QC laboratory systems that includes the measures and activities related to laboratory procedures and processes from sampling to testing and archiving of laboratory records for the new production facility of Dem Pharmaceutical, located in Yalova/Turkey. • Supporting the start-up project activities by managing the quality control laboratory installation, commissioning, qualification, and validation. • Cooperating with all the project members by checking the layouts, flows, equipment requirements and installation plans, etc. • Leading the preparation of the URS documents for the required QC equipments as per the requirements specified in Pharmacopoeias and regulatory guidelines by cooperating with the other related departments (IT, TechOpps, QA). • Organizing all QC equipment IQ/OQ activities. • Leading the SAP S/4 HANA QM Module commissioning process by joining to the conceptual design, URS preparations and IQ/OQ as well as PQ studies. • Ensuring QC lab GMP readiness to support facility start-up, including water (PW, WFI), pure steam (PS) and compressed gas systems. • Leading the daily activities of the QC lab including batch release analyses, stability studies, and starting materials analyses for releasing pharmaceutical products in vial, lyophilized vial and ampoule forms. • Supporting QA Department to carry out process validation and cleaning validation analysis as per related protocols. • Leading laboratory investigations for OOS and OOT events with CAPA implementation. • Providing and giving required training to QC staff including new staff to improve staff's technical qualifications. • Coordinating the analytical method transfer, method validation and method verification studies for analytical, biochemical, physico-chemical, and raw material laboratories. Show less



Nukleon Nuclear Technology

• Türkiye
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Control Manager

  • Nov 2018 - Oct 2020

  • Leading all QC relating activities • Managing QC department (with 4 QC specialist) in line with GMP and other relevant regulations • Evaluating and confirming of final product (PET Radiopharmaceuticals) QC Analyses results according to pre-defined specifications • Development and validation of QC methods for testing PET radio tracers • Creating and maintaining relevant QC SOPs • Investigating and reporting of quality exceptions / manufacture failures • Establishing and approving specifications for release of starting materials and final products • Leading Cost Saving Project Group of the Site. Show less



Bilim İlaç

• Türkiye
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Executive

  • Nov 2017 - Nov 2018

  • Leading and coordinating QC Raw Material Analyses Group Activities • Evaluating and confirming QC Raw Material analyses results on SAP system • Playing an active role in internal and external audits. • Leading Cost Saving Project Group of the Site. • Leading and coordinating QC Raw Material Analyses Group Activities • Evaluating and confirming QC Raw Material analyses results on SAP system • Playing an active role in internal and external audits. • Leading Cost Saving Project Group of the Site.



Biofarma İlaç

• Quality Control Executive

  • Jun 2014 - Oct 2017

  • Leading and coordinating QC Product Analyses Group activities including routine and PV (Process Validation ) analyses of the pharmaceutical products in the forms such as tablet, film-coated tablet, capsule, granule, soft gelatin capsule, suppository, syrup, suspension, solution, spray, dry powder suspension, cream and pomade. • Evaluating and confirming QC Product analyses results on SAP system and providing CoA's for QA department. • Preparing and revising SOP's and MoA's for QC. • Playing an active role in internal and external audits. • Achieving success without any critical and major findings during authority and customer audits. • Completing the actions about audit findings related QC Product Analyses within the predicted time. • Leading laboratory investigations for OOS and OOT events of QC Product Analyses. • Investigation of customer complaints, work with QC, QA together on sources, resolution. • Supporting the customer’s technical questions. • Listening to and synthesizing many perspectives to raise and resolve key questions. • Coordinating AMT (Analytical Method Transfer) studies. • Coordinating in-vitro dissolution profile studies and evaluating the obtained results with respect to related current guidlines. • Providing DPCR (Dissolution Profile Comparison Report) on authority request. • Providing all QC related documents on request of authority or other related departments. (QA, Regulatory Affairs, R&D Departments) • Completing required actions for deviations, change control, and CAPA's. • Making presentations of QC Product Analyses Group's monthly activites based on defined KPI's to QC staff (including QC Manager, Quality Group Manager and Site Director) • Leading Cost Saving Project Group of the Site. • Providing and giving required trainings to QC staff to improve staff's technical qualifications. • Cooperating with other departments (QA, Regulatory Affairs, R&D, Technical Departments). Show less



PharmaVision

• Türkiye
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Quality Control Raw Material Team Leader

  • May 2011 - Jun 2013

• Quality Control Expert Analyst

  • May 2010 - May 2011

• Quality Control Analyst

  • Apr 2009 - May 2010


Kara Harp Okulu / Turkish Military Academy
• Türkiye
• Armed Forces
• 1 - 100 Employee
• Food Control and Hygiene Inspection Officer (Millitary)

  • Apr 2008 - Apr 2009
• Quality Control Analyst

  • Apr 2007 - Apr 2008

• IPC Analyst / QC

  • Jul 2006 - Apr 2007